Cit Biopsy Punches

FDA 510(k) K944444 · Chirurgische Instrumente

Substantially Equivalent

510(k) numberK944444

Submission

Device name
Cit Biopsy Punches
Applicant
Chirurgische Instrumente
Balgheim, DE
Received
August 12, 1994
Decision date
September 29, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HFB – Forceps, Biopsy, Gynecological
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFB

510(k)DeviceApplicantDecision
K011488Spirabrush CX Biopsy InstrumentHFB · Traditional Trylon Corp.02/22/2002SE
K930773Symbiosis Gynecological Biopsy ForcepsHFB · Traditional Symbiosis Corp.07/28/1994SE
K933767Forceps, Biopsy Gynecological Instru/BiopsyHFB · Traditional Mahe-Medizintechnik05/26/1994SE
K926595Owens Biopsy ForcepsHFB · Traditional Owens Industries, Inc.05/25/1994SE
K926527Roto Fit Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/25/1994SE
K930036Thomas Medical Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/24/1994SE
K926538Tischler Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/24/1994SE
K924224Owens Biopsy ForcepsHFB · Traditional Owens Precision Systems, Inc.02/04/1994SE
K902049Croak Ovarian Biopsy ForcepHFB · Traditional Gynescope Corp.06/07/1990SE
K895303Ever-Sharp Biopsy ForcepsHFB · Traditional Southwest Medical Mfg., Inc.01/16/1990SE

More from Southwest Medical Mfg., Inc.

510(k)DeviceDecision
K944270Cit Monopolar Laparoscopic InstrmentsHET · Traditional 07/25/1995SE
K944268Cit Two Way Suctin and Irrigation TubesHET · Traditional 01/26/1995SE
K944269Cit Grasping and Dissecting ForcepsHET · Traditional 01/24/1995SE

Questions and answers

When was Cit Biopsy Punches cleared by the FDA?

Cit Biopsy Punches (K944444) received a 510(k) decision of Substantially Equivalent on September 29, 1995, 413 days after the submission was received.

What is the product code of K944444?

The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.